iVeena announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IVMED-80, for the treatment of keratoconus. Keratoconus is a degenerative disorder causing a cornea to become conical in shape that can seriously distort vision. This may lead to a corneal transplant. IVMED-80 is the first eye-drop, non-surgical, non-laser treatment for medical crosslinking of the cornea.

“Receiving orphan drug designation is an important regulatory milestone, and we are pleased that IVMED-80 for keratoconus has been granted this status,” said Gerald Simmons, CEO of iVeena Delivery Systems. “We are developing IVMED-80 to potentially offer advantages over the standard of care and our team is committed to advancing the clinical development program.”

The Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people in the United States. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval.

iVeena Completes Phase 1/2a Pilot Clinical Study for IVMED-10, a Bioerodable, Sustained Release, Intracapsular Implant that Delivers Dexamethasone to Both Anterior and Posterior Eye Segments to Treat Inflammation and Pain Associated with Cataract Surgery.

A total of eight patients were enrolled in the Phase 1/2a, single site, clinical study. Seven patients completed the study. An independent clinical trial report indicated that IVMED-10 was safe and effective for the control of inflammation typically observed following cataract surgery. Retinal thickness outcomes are comparable to published data of NSAID and steroid standard of care therapy. All adverse events including elevated IOP, corneal edema, and pain were transient in nature. All patients had 20/25 BCVA or better at the end of the study.

iVeena has additional clinical studies of IVMED-10 and initial studies of IVMED-20 planned for 1Q 2018.

About IVMED-10 & IVMED-20
IVMED-10 is a sustained release implant that delivers dexamethasone for 2 weeks that is placed in the lens capsule during the time of cataract surgery. It is intended for patients undergoing routine cataract extraction. IVMED-20 is a sustained release implant that delivers dexamethasone for 6 weeks. The product is placed in the lens capsule at the time of cataract surgery and is intended for patients that are at risk of developing retinal thickening in association with complicated cataract extraction.

"iVeena is pleased to receive a total of $450K in Federal Government grants to advance its portfolio programs," said Gerald Simmons, CEO. "$225K is an NIH grant for its Keratoconus Orphan Drug candidate. IVMED-80 is the first eye-drop, non-surgical, non-laser treatment for medical crosslinking of the cornea. $225K is an NSF grant for iVeena’s Gene Therapy program for various ophthalmic applications.”

1. SBIR Phase 1 by the NIH NEI Principal Investigator(s): Sarah Abdulla Molokhia, PHD Project Title: Topical Eyedrop Therapy for Keratoconus FAIN: R43EY027636
2. SBIR Phase 1 by the NSF. Principal Investigator (s): Sarah Abdulla Molokhia, PHD Project Title: Dual suppression of VEGF-A and PDGF-B with extended gene therapy for neovascular AMD FAIN: 1721400

On Monday, May 30th, iVeena initiated the Phase I/2a pilot clinical study for IVMED-10. This product is a bioerodable dexamethasone implant given at the time of cataract surgery that releases the drug in the lens capsule over an approximate two week period. “This product is designed to eliminate the need for daily administration of a steroid and an NSAID that published reports show is highly confusing and difficult for a significant portion of the older target population that under go cataract surgery," said Jerry Simmons, CEO. The market for post surgery cataract drops exceeds $1B annually. Results of the study should be available late July or early August, this year.

iVeena to present at the BioTech Showcase Conference that runs in parallel with the JP Morgan Conference in San Francisco on Wednesday, January 11, 2017

Glaucoma affects approximately three million individuals in the US and can lead to blindness if not treated. The current standard of care is to administer eye drops on a daily basis that results in a high level of patient non-compliance and the resulting series side effects. The first MIGS device to eliminate the need for eye drops was recently approved. iVeena has developed what we consider is an improved product (increased aqueous outflow) compared to the currently marked products. “The USTAR TAP grant will allow iVeena to accelerate its pre-clinical development of this product and improve our chances of moving forward to clinical studies" said Jerry Simmons, CEO.

Dr. Peter Hnik Appointed Chief Medical Officer

Peter Hnik, MD, MHSc has been appointed Chief Medical officer of iVeena Delivery Systems Inc. Dr. Hnik will oversee the expansion of the iVeena clinical trials program and related regulatory issues. Dr. Hnik is an ophthalmologist by training and has had considerable corporate experience in these areas including Chief Medical Officer for iCo Therapeutics and Associate Director for QLT Inc., both ophthalmology product companies. "We are quite pleased to have Dr. Hnik as part of the iVeena team during this critical expansion phase for the company," said Jerry Simmons, CEO. "His experience is a great fit for our current and future needs in the clinical and regulatory areas."